BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    PMA: P820077 · Decision Nov 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum
    Trade Name
    AFP MID-PREGNANCY REFERENCE PREPARATION
    PMA Number
    P820077
    Device Class
    FDA Class 3
    Product Code
    LTQ
    Generic Name
    CALIBRATOR FOR ALPHA-FETOPROTEIN IN MID-PREGNANCY MATERNAL SERUM
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 30, 1984
    Date Received
    October 19, 1982
    Expedited Review
    N
    Docket Number
    84M-0410

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTQ Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum